BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Valencia
About this trial
1. To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments. 2. To establish the BMI at which this disease occurs. 3. To establish how much the BMI must be reduced to cure this disease. 4. To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older at the time of enrollment. There is no upper age limit to ensure inclusivity across age ranges.
A confirmed diagnosis of Idiopathic Intracranial Hypertension, established according to the Dandy criteria.
The diagnostic process must exclude other potential causes of increased intracranial pressure as detailed in the 'Diagnosis' section, ensuring an accurate identification of idiopathic cases.
Disqualifiers
A diagnosis other than IIH, specifically: tension-type headache, Chiari I malformation, or any other headache disorder unrelated to IIH.
The presence of secondary causes of increased intracranial pressure (e.g., structural brain abnormalities, venous sinus thrombosis, or medication-induced factors).
Trial population
This study is designed to be a retrospective-prospective cohort study. Data was collected from all retrospective patients attended in the last 10 years by the Neurosurgery department at Hospital General Universitario de Valencia who presented idiopathic intracranial hypertension (IIH) and were accepted to participate. Data were extracted and reviewed from the patient's medical records.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Weight loss without pharmacotherapy
Other interventionThe study will record the weight of the patients with Idiopathic Intracranial Hypertension every three months. It will correlate with the response to the different treatment modalities (weight loss with no other intervention, diuretic drugs (acetazolamide), lumboperitoneal shunt, or ventriculoperitoneal shunt). No medication will be provided to help lose weight.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Patients with Idiopathic Intracranial Hypertension1 intervention
Trial outcomes
Primary outcomes
1
Response to treatment
BMI evolution in patients with benign intracranial hypertension and its relationship with the evolution of the patient's symptoms
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov